Regulatory Compliance Specialist

7 days ago

Cape Town, Western Cape, South Africa O'Brien Recruitment Full time

Job Overview:

O'Brien Recruitment is seeking an experienced Quality Assurance Pharmacist to join our team in a key regulatory compliance role within the pharmaceutical industry.

Key Responsibilities:

  • Maintain strict adherence to ISO 9001 and ISO 22716 standards across all areas of the organization, ensuring seamless alignment with Good Manufacturing Practices (GMP) and legal requirements.
  • Conduct thorough root cause investigations and implement corrective actions to prevent recurrence, maintaining a culture of quality and excellence.
  • Facilitate effective non-conformance meetings to ensure prompt resolution of issues, promoting open communication throughout the organization.
  • Oversee the execution of annual QMS reviews per ISO standards, guaranteeing continuous improvement and growth.
  • Conduct internal and supplier audits, followed by follow-up meetings with relevant managers or suppliers to address findings, fostering strong partnerships and collaborations.
  • Manage the customer complaints process efficiently, addressing concerns promptly and ensuring complete satisfaction.
  • Lead the distributor satisfaction survey process, driving business growth through enhanced relationships and services.
  • Handle Change Control processes effectively, escalating critical issues to the QA Manager when necessary, while chairing Change Control meetings to drive timely decision-making.
  • Ensure products are properly controlled, adhering to standard procedures and conducting batch releases (e.g., supplements), upholding the highest standards of quality.
  • Hold regular hygiene feedback meetings with managers to discuss findings, address deviations, and promote ongoing improvement.
  • Promote organizational compliance with cosmetic and pharmaceutical cGMP standards, maintaining the highest level of regulatory adherence.
  • Deliver relevant monthly or quarterly reports to the Quality Assurance Manager, providing actionable insights and recommendations for growth and improvement.

Requirements and Qualifications:

  • Minimum of 2 years' experience as a Quality Assurance Pharmacist in a manufacturing environment, with a proven track record of success.
  • Strong background in production and quality assurance, combined with excellent attention to detail, communication skills, and presentation abilities at all organizational levels.
  • In-depth knowledge of PICS, SAHPRA, ISO 9001, and ISO 22716 requirements, enabling you to drive regulatory compliance and excellence.
  • Proficiency in MS Office, coupled with excellent analytical and problem-solving skills, allowing you to drive results-oriented solutions.

Qualifications:

  • Bachelor of Pharmacy degree from a reputable institution.
  • Registered with the South Africa Pharmacy Council, demonstrating your commitment to professional excellence.

Estimated Salary: $80,000 - $120,000 per annum, depending on experience and qualifications.

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